As a pioneer in the development of automated validation software solutions, ValGenesis, Inc. leads the way with a unique paperless validation process that tracks the validation status of any GxP system in real time. With years of development and refinement in place, ValGenesis is the first to offer users real-time paperless validation via electronic execution thereby minimizing ineffectiveness and maximizing efficiency. ValGenesis automates and manages the validation life cycle and provides real time validation status of any system corporate wide.

1.
PDA awarded ValGenesis the New Innovative Technology award for
Paperless Validation Lifecycle Management Technology
Benefits of an
Electronic Validation Lifecycle Management System
in the CorporateValidation Process –
Validation CycleTime and Cost Perspective
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2. Regulated Pharmaceutical, Biotech and Medical Device companies are challenged to develop manufacturing capabilities
quickly and cost-effectively, while safeguarding product quality and patient safety. Validation has been an essential part
of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business or the manual
approach to validation. Over time the traditional validation activities have become centered on documentation, which has
increased and led to additional quality issues. For the most part, validation still requires a high degree of manual effort, for
tracking and reporting, and the execution of most validation protocols takes place on paper.
Traditional validation activities using paper-based validation processes stifle innovation, cause compliance risks and
compromise a life science firm’s ability to bring products to the market on time. Inefficiencies in the validation process
cost regulated manufacturers millions of dollars annually, mainly attributed to the use of paper, or paper/hybrid electronic
systems. These manual, or hybrid, labor-intensive systems are proven to be error-prone, delay time-to-market and
introduce product quality problems that risk stringent regulatory penalties.
Validation lifecycle activities are separated into the following two major categories, for efficiency estimation,
1. Core Validation activities 2. Supporting Validation activities
1.0 Core Validation activities:
Core validation activities constitute 80% of the overall Validation Lifecycle. The following are the core validation
constituents and the associated effort required for the validation lifecycle.
1.1 Creating, reviewing and approving Validation plans and projects – 5%
1.2 Authoring, reviewing and approving Validation protocols – 25%
1.3 Creating and maintaining traceability matrices and requirements – 10%
1.4 Executing, reviewing and approving Validation protocols – 25%
1.5 Risk assessment, review approval and maintaining the Validation status -10%
1.6 Creating and maintaining periodic review and revalidation schedules – 5%
Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process
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3. # Current Process Impact of ValGenesis Efficiency Gain
1.1 Creating, reviewing and approving Validation plan and projects –
5% of the effort in the Validation Lifecycle Process
1.1.1 Validation Plans and projects are created
manually and routed for review and
approvals through inter-office mail.
Approved validation plans are available
as reference but cannot be enforced in
the process.
Validation plans and projects can be developed electronically
and routed for review and approval through workflow.
Approved Validation plan and requirements are enforced in the
process and eliminate the risk of noncompliance
Given these advantages
of creating validation
plans and projects
in ValGenesis, it is
expected to achieve a
20-30% efficiency gain
in this area.
1.2 Authoring, reviewing and approving Validation protocols –
25% of the effort in the Validation Lifecycle Process
1.2.1 In a paper environment, once a
document has been authored or
executed, it must be physically sent
to the corresponding reviewers or
approvers through inter-office mail, or
other delivery options. Paper documents
can be misplaced or lost, causing time
to be spent searching for, or replacing
documents.
Furthermore, routing documents from
one location to the next, adds additional
delays. There will be a number of
reviewers and approvers. Documents
have to be routed to each reviewer, or
approver, in a serial flow.
In ValGenesis authored documents are routed electronically and
are available for review and approval in real time. ValGenesis
supports routing in parallel, serial and a combination of parallel
and serial (hybrid) reviews and approvals, to expedite the final
approval process. Every document, its history and current status
are available electronically ensuring solid and secure document
control.
Parallel Review - Documents can be reviewed in parallel,
whereby all reviewers can review documents at the same time.
Combination of Parallel and Serial Review: Documents can be
reviewed in parallel by the first few reviewers and approvers,
the final approval can be done in serial (one QA Approver for
example).
ValGenesis supports the reuse of requirements and developed
protocols, through a binding process, for entities to be validated.
Given these advantages
of authoring, reviewing
and approving
validation documents
in ValGenesis, it is
expected to achieve a
20-30% efficiency gain
in this area.
1.2.2 In the current process, there is no
method available to alert reviewers and
approvers regarding target dates, or any
delay in the process.
It is difficult to transfer the tasks to other
reviewers and approvers, in the event of
delay.
Alert Notification - Reviewers are alerted, in real time, of any
waiting review or approval task, through corporate email.
1.2.3 Physical access to the document is
required for review, or approval of the
document.
Review or approval is delayed if the
reviewer or approver is not available.
No Physical access is required; documents can be sent securely
through corporate networks.
1.3 Creating and maintaining traceability matrices and requirements –
10% of the effort in the Validation Lifecycle Process
1.3.1 Creating and maintaining a traceability
matrix through a manual process is
extremely time consuming. The traces
between requirements and test cases are
generally buried in the paper and cannot
provide any real time information, or
impact assessment.
Traceability Matrices can be created dynamically within few
mouse clicks in ValGenesis. The Traceability Matrix function
within ValGenesis improves change management by providing
an accurate assessment of its impact, by identifying related
requirements, design elements, and test scripts. In addition, it
helps to scope the regression testing clearly and accurately.
During test case execution, the deviations observed in a test
case can be tracked and traced back to the associated design
elements in the Traceability Matrix.
During audits and inspections, the Traceability Matrix provides a
clear, real-time view of the trace between requirements, design
elements and test cases.
Given these
advantages of creating
and maintaining
requirements and
traceability matrices
in ValGenesis, it is
expected to achieve a
40-50% efficiency gain
in this area.
1.3.2 Developing requirements takes significant
effort and coordination between all
users.
Requirements are subject to frequent
changes and version control should
be adopted. It is time-consuming and
difficult to maintain requirements in the
paper-based process
ValGenesis provides a collaborative approach to effectively
communicate with all users, through a requirements bulletin
board, reducing the time to complete the requirement
gathering process.
ValGenesis provides the functionality to maintain the
requirements, with version control. This approach provides
much more control and significantly reduces the time to
maintain the requirements.
Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process
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4. # Current Process Impact of ValGenesis Efficiency Gain
1.4 Executing, reviewing and approving Validation protocols –
25% of the effort in the Validation Lifecycle Process
1.4.1 Documents have to be executed
manually with pen and paper. Screen
shots have to print through a printer and
attached, with the executed document,
as attachments. Supporting files, such as
reports, will also be attachments to the
executed document.
Documents are executed electronically and screen shots are
attached at the test case row level. Files can also be attached at
the row level.
Given these advantages
of executing, revising
and approving
validation documents
in ValGenesis, it is
expected to achieve a
40-50% efficiency gain
in this area.
1.4.2 Deviations or exceptions are handled
manually through paper-based
documents. Each deviation will be
handled through a separate time-
consuming paper-based workflow.
Deviations are handled electronically and the deviation
workflows are concurrent for any number of deviations, this will
expedite the execution process.
1.4.3 Hand-writing can be difficult to read and
may contain typographical errors
ValGenesis provides spell-checking and all content is electronic
and easy to read.
1.4.5 Once the document has been executed
it must be physically sent to the
reviewers or approvers, through inter-
office mail, or other delivery options.
Furthermore, routing documents from
one location to the next adds additional
delays. There will be a number of
reviewers and approvers. The documents
have to be routed to one reviewer or
approver in a serial flow.
In ValGenesis executed documents are routed electronically
and are available for review and approval in real time.
ValGenesis supports parallel, serial and combination of parallel
and serial (hybrid) review and approval, to expedite the process.
Parallel Review – Executed documents can be reviewed in
parallel; whereby all reviewers can review the document at the
same time.
Combination of Parallel and Serial Review: Executed documents
can be reviewed in parallel by the first few reviewers and
approvers, the final approval can be done in serial (one QA
Approver for example).
ValGenesis supports the reuse of requirements and developed
protocols, through a binding process with other entities, to be
validated.
1.4.6 There is no automated method to alert
reviewers and approvers regarding target
dates, or delays in the process.
It is difficult to transfer the tasks to other
reviewers or approvers, in the event of a
delay.
Alert Notification - Reviewers are alerted in real time of any
review or approval task, through corporate email.
Tasks may be transferred to other reviewers and approvers
automatically should there be a delay
Management is notified of delays and can take any necessary
action.
1.4.7 Physical access to the executed
document is required for review, or
approval.. Review or approval is delayed
if a reviewer or approver is not available.
No physical access is required; documents can be approved
through secure corporate networks.
1.4.8 There is great potential to misplace or
lose executed document during transfers
Documents are available in electronic format and are stored
centrally for easy access.
1.5 Risk assessment, review, approve and maintain the validation status -
10% of the effort in the Validation Lifecycle Process
1.5.1 Risk assessment is manual and again
generally paper-based; this requires
information from a number of different
systems, or departments. This is a time-
consuming and error-prone process.
ValGenesis brings together all the impacts associated with the
validated systems/entities for assessment. For example, the
associated change requests, upcoming revalidation/periodic
review etc. are pulled together. This means all the impacts can
be brought together in fewer documents electronically.
Given these advantages
of managing the risks
in ValGenesis, it is
expected to achieve a
40-50% efficiency gain
in this area.
1.5.2 Approval of risk assessment is generally
managed through manual and paper-
based processes, it is extremely time-
consuming.
ValGenesis provides comprehensive workflow capabilities to
manage the risk assessment.
1.5.3 There are no automated alerts for SMEs
should there be any impact on the
validation status of systems/entities.
ValGenesis automatically alerts SMEs if there is any impact.
Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process
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5. # Current Process Impact of ValGenesis Efficiency Gain
1.6 Create and maintain periodic review and revalidation schedules –
5% of the effort in the Validation Lifecycle Process
1.6.1 Periodic review and revalidation
schedules are maintained in paper. It is
very time-consuming and error-prone.
ValGenesis provides a dynamic validation calendar for
upcoming and delayed periodic reviews and revalidations
Given these advantages
of maintaining periodic
review and revalidation
schedules in ValGenesis,
it is expected to achieve
a 40-50% efficiency
gain in this area.
1.6.2 Periodic review and revalidation
schedules are generally approved
through a paper-based process.
Workflow-driven review and approval for Periodic review and
revalidation schedules.
1.6.3 No automatic alerts for upcoming, or
delayed, revalidation or periodic review
schedules.
ValGenesis provides automatic alerts for upcoming and delayed
periodic reviews and revalidations; this helps to eliminate the
possibility of missing a validation task due to human-error.
2. Supporting Validation Activities:
Supporting validation activities consist of 20% of the overall Validation Lifecycle. The following are the supporting
validation activities and associated effort required in the validation lifecycle.
2.1 Tracking the validation status for decision-making 10%
2.2 Audit preparation for internal and external audits – 3%
2.3 Document retrieval – 2%
2.4 Validation metrics for resource and budget planning – 5%
# Current Process Impact of ValGenesis Efficiency Gain
2.1. Tracking the validation status for decision-making
2.1.1 In a paper-based system, tracking is difficult
at best, as it often requires e-mails, or phone
calls, to prospective reviewers, approvers, and
document specialists.
ValGenesis is equipped with built-in tracking functions,
designed to enable users to locate an authored, or
executed document easily and in real time. These
functions include development and execution pie-charts
from the dashboard, inventory manager with search
capabilities, barcode scanning from the production floor,
and transparent audit trails available to any user involved
with developing, execution, reviewing, or approving any
document.
Given these
advantages of real
time tracking functions
in ValGenesis, it is
expected to achieve
a 70-80% efficiency
gain in this area.
2.2 Audit preparation for internal and external audits
2.2.1 With paper-based systems, audit preparation
is much more cumbersome, given that
documents must be located in a physical
document repository. Furthermore, when
documents are not available, there is
additional delay in physically routing the
document to the intended receiver.
All documents are generated electronically in ValGenesis
and can be retrieved from the system’s electronic
repository (Library), in real time. This means users can be
prepared for audits with very little effort finding documents
in a few mouse clicks.
Given these
advantages of audit
readiness through
ValGenesis, it is
expected to achieve
a 80-90% efficiency
gain in this area.
2.3 Document retrieval
2.3.1 Documents have to be searched and retrieved
from a physical document storage location.
This method has a high cost of maintenance
and needs extra resources.
Documents can be retrieved in real time. Documents are
available electronically in real time. There is no need for
physical document storage and the resources to manage
them.
Given these
advantages of
ValGenesis, in terms of
document availability
and retrieval, it is
expected to achieve
a 70-80% efficiency
gain in this area.
Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process
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6. Contact Information:
47102 Mission Falls Court | Ste 218, Fremont, CA 94539
Phone: 1-888-825-4363 & (510) 445-0505 | Fax: (510) 991-9901
www.valgenesis.com | Email: info@valgenesis.com
One of the greatest challenges facing regulated
companies is the high cost associated with the initial
validation, subsequent change management and
revalidation to maintain the validation status throughout
the life cycle for any entity. In fact, the costs associated
with traditional paper-based validation, represent
approximately one-third of the total resources required
for overall implementation. With the traditional manual
validation processes, the costs also include significant
amounts of review and approval time, for developed and
executed documents, as well as the time to manage
results and track the validation status and protocols.
Unfortunately, these high costs can stifle innovation in
life science companies, and compromise the ability to
bring new products to market efficiently.
ValGenesis is designed to manage the entire Validation
life cycle electronically and remove the inefficiencies
that plague paper-based processes; ValGenesis helps
to reduce the cost of validation, allowing optimization
and stabilization of existing processes, plus electronic
management (document authoring, test execution,
review and approval) of validation processes and
procedures. This reduces the cost of the validation
process by eliminating much of the paper-based
documentation and process/procedure approvals.
ValGenesis is expected to reduce the cost and time
of Validation Lifecycle process by 30-40%, when the
system is configured to meet specific validation process
flows and adequate training for users.
# Current Process Impact of ValGenesis Efficiency Gain
2.4 Validation metrics for resource and budget planning
2.4.1 No metrics available in the paper-based
system, difficult to control costs and estimate
budgets.
ValGenesis provides metrics for budgeted vs. actual
results, allowing efficient planning and cost control.
Given these
advantages of the
real time metrics
functionality in
ValGenesis, it is
expected to achieve
a 50-60 % efficiency
gain in this area.
2.4.2 No mechanism to track the performance
of the individuals involved in the validation
process, based on their contribution.
ValGenesis can track the performance of individual users
within the system.
Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process
Copyright © 2009, ValGenesis inc.. All rights reserved.
This document is provided for information purposes only and the contents hereof are
subject to change without notice. This document is not warranted to be error-free,
nor subject to any other warranties or conditions, whether expressed orally or implied
in law, including implied warranties and conditions of merchantability or fitness for a
particular purpose. We specially disclaim any liability with respect to this document and
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ValGenesis is a registered trademark of ValGenesis Inc. and/or its affiliates. Other names
may be trademarks of their respective owners.
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